MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 115" (292 CM) 20 DROP BLOOD SET, BIFUSE W/200 MICRON FILTER, HAND PUMP, REMV 2-G; STOPCOCK, I.V. SET

Catalog Number	AC234
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unkonwn.(b)(6) 2024 have been used as a placeholder d4 and h4 - without a lot# the manufacturing and expiration dates are unknown.E1 phone number - not provided.
Event or Problem Description
A complaint involving a 115" (292 cm) 20 drop blood set, bifuse w/200 micron filter, hand pump, remv 2-gang 4-way nanoclave¿ stopcocks, spin luer, 1 ext experienced separation on an unknown date.It was reported the iv line broke off mid case.There was patient involvement, and unknown human harm.In addition to the documentation mentioned above, a sample picture has been provided to icu medical showing two devices that were broken off.
Additional Manufacturer Narrative
One photograph was provided by the customer for investigation, the complaint of "iv line broke off mid case" can be confirmed from the photograph provided.No ac234 product samples were returned for investigation.The device lot history was not reviewed, no lot number information was provided.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 115" (292 CM) 20 DROP BLOOD SET, BIFUSE W/200 MICRON FILTER, HAND PUMP, REMV 2-G
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20269102
• Report Number: 9617594-2024-01318
• Device Sequence Number: 17026990
• Product Code: FMG
• UDI-Device Identifier: 00887709120181
• UDI-Public: 00887709120181
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AC234
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown